A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis
Completed · Phase 1 · Has a placebo group
Conditions studied: Bacterial Vaginosis
In brief
This is a two-part, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy (for Part B) of BNT331 in healthy women (Part A) and in women diagnosed with bacterial vaginosis (BV) (Part B).
Key facts
- Study ID
- NCT06469164
- Run by
- BioNTech SE
- People needed
- 102
- Starts
- 2024-07-01
- Expected to finish
- 2025-07-31
- Last updated by the study team
- 2025-08-07
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
Where it is running
- UAB Sexual Health Research Clinic — Birmingham, Alabama, United States
- Praetorian Pharmaceutical Research, LLC — Marrero, Louisiana, United States
- Southern Clinical Research Associates - Metairie — Metairie, Louisiana, United States
- Women Under Study, LLC — New Orleans, Louisiana, United States
- Nucleus Network — Saint Paul, Minnesota, United States
- Chattanooga Medical Research, LLC — Chattanooga, Tennessee, United States
Full record on ClinicalTrials.gov
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